The years of crisis-plagued government drug manufacturing company in Kerala, Kerala State Drugs and Pharmaceuticals Ltd (KSDP), is now showing signs of development and growth with the establishment of a state-of-the-art drug testing laboratory and a beta lactam injection plant at its premises in Alappuzha, according to information from the company sources.

Drugs production at the company was held only for the requirement of the state until a few years ago since its inception in 1974. But, crisis started when the government procurement agency, Kerala Medical Services Corporation Ltd (KMSCL), stopped purchase in 2012 citing quality problems.

Now a well-equipped modern lab is ready for operation, but delay in getting licence from the state drugs control authority and accreditation from the national accreditation board (NABL) is the bottleneck to open the lab for public and private uses. NABL certification is necessary for all drug testing labs at present, K.B. Jaya Kumar, managing director of the firm told Pharmabiz.

“The lab was set up with the support of the government, spending three crores of rupees, with all modern GMP facilities to check the quality of drugs produced by the company. Over 50 varieties of tablets and other drugs are being produced in the company at present. NABL recognition is needed to export the medicines produced in the company. Once it is commissioned, its facility can be used for all kinds quality tests not only for drugs, but also for those consumer products like food, vegetables, alcoholic beverages etc,” he said.

Regarding capacity of the lab, M. Santhosh, the production manager at the company, said about 50 samples can be tested at the unit per day. The laboratory is helpful for the drugs control department to reduce their burden of testing at their laboratory at Thiruvananthapuram. Currently, the DCA is checking qualities of samples at their own unit and the process is time-consuming.

“After formally opening the laboratory at KSDP, the departments of food, drugs and excise can check the quality of samples in this lab and get the results without delay,” he added.

The company’s new set up, a beta-lactam antibiotics injection plant, is also ready for functioning. It will be commissioned in three months time. Once the unit is started functioning, it will have the capacity to produce the entire range of beta-lactam injectables and it can cater to the total requirement of the state, said Santhosh.

KSDP is now getting purchase orders from Andra Pradesh and Telangana states for various antibiotics in addition to the orders from KMSCL.